MAUDE Adverse Event Report: MEDTRONIC IRELAND TALENT OCCLUDER; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	OCL12US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	06/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: o cl14us, serial/lot #: (b)(4), ubd: 12-apr-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system and talent occluder plugs were implanted in a patient for the emergency endovascular treatment of a ruptured abdominal aortic aneurysm.It was reported that the patient presented with a ruptured abdominal aortic aneurysm and was grey in color upon arrival.It was reported that the physician chose the sizing of the devices via angiogram choosing an endurant aui and a 16x24x93 endurant limb.Two talent occluder plugs were implanted on the right side to occlude the iliac artery.Once the evar procedure was completed the procedure transitioned to a fem-fem bypass.It was reported that the patients¿ blood pressure was low during the entire procedure and remained low after the evar.The physician remarked that the patients abdomen felt like a drum and the decision was made to open up the abdomen to explore for internal bleeding, none was found yet the patients¿ blood pressure kept dropping.Resuscitation was attempted for 20 minutes but the patient expired.As per the physician, the cause of the event was due to multiple comorbidities; chronic renal failure and shock.The definitive cause of the rupture could not be determined.No additional clinical sequelae were reported.

• Brand Name: TALENT OCCLUDER
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7637046
• Report Number: 2953200-2018-00892
• Device Sequence Number: 2413035
• Product Code: MIH
• UDI-Device Identifier: 00613994573148
• UDI-Public: 00613994573148
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2019
• Device Model Number: OCL12US
• Device Catalogue Number: OCL12US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 75 YR